Tests scans and biomarkers to predict response to immunotherapy before surgery in lung cancer
Tests nivolumab with chemotherapy before surgery in early-stage non-small cell lung cancer.
Plain-language title generated from the registry record
Registry title: Metabolic Biomarkers Predicting Response to Neoadjuvant Immunotherapy in Non-Small Cell Lung Cancer
Key facts
- Where
- Ribeirão Preto, BrazilSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with non-small cell lung cancer in an early stage that can be removed by surgery. They will get immunotherapy plus chemotherapy before surgery.
- Age
- 18 years or older
- Sex
- Women and men can join
- Disease stage
- Non-small cell lung cancer, clinical stage IB to IIIA, confirmed under the microscope. The team must judge the tumor can be removed by surgery.
- Earlier treatment
- Cannot have had any earlier drug treatment, radiotherapy or immunotherapy for lung cancer.
- Biomarker or test result
- No known EGFR mutation and no known ALK rearrangement.
Main reasons for not taking part
- Earlier drug treatment, radiotherapy or immunotherapy for lung cancer
- Known EGFR mutation or ALK rearrangement
- Autoimmune disease needing systemic treatment in the past 2 years
- Pregnant or breastfeeding women
- Another cancer in the last 3 years, with a few exceptions
Read by machine on 12 November 2026.
Where in Brazil
- Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HC-FMRP-USP)Ribeirão Preto, BrazilContact: Saulo B Silva, Associate Professor, MD, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Hospital das Clínicas de Ribeirão Preto
- Trial code
- NCT07084610
- Record updated
- 17 September 2026
- Original description
This study investigates metabolic glycolytic biomarkers obtained from radiological imaging (18F-FDG PET/CT), immunohistochemistry (IHC), and molecular analyses, and their association with response to neoadjuvant immunotherapy in early-stage non-small cell lung cancer (NSCLC).Read full original descriptionShow less
Metabolic Signatures Predictive of Response to Neoadjuvant Immunotherapy in Non-Small Cell Lung Cancer
This study investigates metabolic glycolytic biomarkers obtained from radiological imaging (18F-FDG PET/CT), immunohistochemistry (IHC), and molecular analyses, and their association with response to neoadjuvant immunotherapy in early-stage non-small cell lung cancer (NSCLC).
Objective: To evaluate the relationship between glycolytic biomarkers measured by PET/CT (metabolic tumor volume and SUVmax), IHC markers (GLUT-1, Ki-67, PD-L1), and molecular oncogenic alterations, with the pathological response after two cycles of neoadjuvant nivolumab (3 mg/kg) combined with platinum-based chemotherapy in patients with early-stage NSCLC [stage IB (tumor ≥4 cm) to IIIA], negative for EGFR and ALK mutations.
Methods: This is a prospective, single-arm clinical study at a single institution, enrolling 30 patients. Baseline metabolic tumor volume (MTV) and SUVmax will be measured by PET/CT, while IHC markers and molecular profiling will be performed on pre-treatment biopsy samples. Patients will receive neoadjuvant treatment with nivolumab (3 mg/kg, IV) combined with platinum-based chemotherapy (cisplatin 75 mg/m² or carboplatin AUC 5, plus pemetrexed 500 mg/m² for non-squamous or paclitaxel 175 mg/m² for squamous tumors) every 21 days for two cycles. All patients will undergo invasive mediastinal staging before treatment and will be treated with robotic-assisted anatomical lung resection and mediastinal lymphadenectomy after neoadjuvant therapy. Primary outcomes include major pathological response (≤10% viable tumor cells) and immune profile characterization (IHC for CD8, CD4, FOXP3, PD-1, CD68, CD163). Secondary outcomes include event-free survival and treatment toxicity.
Standard of Care: Neoadjuvant chemotherapy regimens and PET/CT scans are part of the institutional standard of care for NSCLC patients.
Conclusion: The study aims to develop a practical diagnostic approach using metabolic glycolytic biomarkers to improve selection of patients likely to benefit from neoadjuvant immunotherapy. It is expected that patients with lower glycolytic activity will have higher rates of major pathological response after two cycles of neoadjuvant nivolumab (3 mg/kg) combined with chemotherapy. These findings may support a more cost-effective immunotherapy regimen for early-stage NSCLC.
Inclusion: Histologically confirmed non-small cell lung cancer (NSCLC), clinical stage IB to IIIA (according to AJCC 8th edition); Tumor deemed resectable by the multidisciplinary thoracic oncology team; Eastern Cooperative Oncology Group (ECOG) performance status 0-1; Adequate organ and bone marrow function; Ability to understand and willingness to sign a written informed consent.
Exclusion: Prior systemic therapy, radiotherapy, or immunotherapy for lung cancer; Contraindications to surgery or anesthesia; Active autoimmune disease requiring systemic therapy within the past 2 years; Uncontrolled comorbidities or active infections; Known history of other malignancies within the last 3 years, except for adequately treated basal or squamous cell skin cancer, or carcinoma in situ of the cervix; Known EGFR mutations or ALK rearrangements; Pregnant or breastfeeding women.